Home Applications 020918 Application 020918
Type NDA
Sponsor NOVO NORDISK Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GLUCAGEN GLUCAGON HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/VIAL Yes Yes 002 GLUCAGEN GLUCAGON HYDROCHLORIDE POWDER;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020918-001 GLUCAGEN GLUCAGON HYDROCHLORIDE EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAMUSCULAR, INTRAVENOUS RLD 1998-06-22 N020918-002 GLUCAGEN GLUCAGON HYDROCHLORIDE EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS RLD 1998-06-22
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 2 of 2 · 62 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020918-001 GLUCAGEN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1998-06-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020918-001 GLUCAGEN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1998-06-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020918-001 GLUCAGEN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1998-06-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020918-001 GLUCAGEN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1998-06-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020918-001 GLUCAGEN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1998-06-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020918-001 GLUCAGEN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1998-06-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020918-001 GLUCAGEN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1998-06-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020918-001 GLUCAGEN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1998-06-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020918-001 GLUCAGEN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1998-06-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020918-001 GLUCAGEN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1998-06-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020918-001 GLUCAGEN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1998-06-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020918-001 GLUCAGEN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1998-06-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020918-001 GLUCAGEN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1998-06-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020918-001 GLUCAGEN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1998-06-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020918-001 GLUCAGEN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1998-06-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020918-001 GLUCAGEN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1998-06-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020918-001 GLUCAGEN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1998-06-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020918-001 GLUCAGEN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1998-06-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020918-001 GLUCAGEN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1998-06-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020918-001 GLUCAGEN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1998-06-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020918-001 GLUCAGEN EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAMUSCULAR, INTRAVENOUS RLD 1998-06-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020918-002 GLUCAGEN EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS RLD 1998-06-22 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0169-7065 GlucaGen HypoKit glucagon hydrochloride Novo Nordisk NDA Current 0169-7065 GlucaGen HypoKit glucagon hydrochloride Novo Nordisk NDA Current 0169-7065 GlucaGen HypoKit glucagon hydrochloride Novo Nordisk NDA Current 0169-7065 GlucaGen HypoKit glucagon hydrochloride Novo Nordisk NDA Current 0169-7065 GlucaGen HypoKit glucagon hydrochloride Novo Nordisk NDA Current 0597-0053 GlucaGen glucagon hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0053 GlucaGen glucagon hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0053 GlucaGen glucagon hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0053 GlucaGen glucagon hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0053 GlucaGen glucagon hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0260 GlucaGen glucagon hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0260 GlucaGen glucagon hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0260 GlucaGen glucagon hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0260 GlucaGen glucagon hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0260 GlucaGen glucagon hydrochloride Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current